The Cobas Amplicor HIV-1 Monitor Test (version 1.5) is an automated in vitro assay that can measure viral loads as low as 50 copies of HIV-1 RNA per millilitre (c/mL) of plasma. This level of sensitivity is critical for optimizing treatment strategies, because maintaining an infected patient’s viral load below 50 c/mL (undetectable) has been associated with a more complete and durable viral suppression.
This assay is the automated version of the Amplicor HIV-1 Monitor Test (version 1.5) that received FDA approval last year. It is for use on the Cobas Amplicor analyzer, an instrument that automates critical steps (amplification and detection) of the PCR process. The test facilitates the quantification of HIV-1 RNA over the range of 50-750,000 copies/mL. Accurate monitoring of viral load levels, in conjunction with clinical presentation and other laboratory markers, may be used to assess patient prognosis, monitor anti-retroviral therapy and clinically manage HIV-1 infected patients.
The Cobas Amplicor HIV-1 Monitor Test (version 1.5) also has the enhanced ability to quantify HIV-1 Group M subtypes A-G. While HIV-1 subtype B continues to predominate in western countries, studies now confirm that the incidence of HIV-1 non-B subtypes is increasing all over the world. A test’s ability to detect a broader range of these genetically diverse viruses will, therefore, be crucial to HIV patient care on a global basis.
Roche Diagnostics
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Keywords: disease management, HIV, molecular diagnostics, STD, infectious disease
